| Code | 7826E | ||||||||||
| MA number | 30/0184/24-S | ||||||||||
| Product Form: | tbl flm 14x15 mg (blis.PVC/PVDC//Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 15.11.2024 |
| Validity: | 15.11.2029 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Vortioxetín STADA 15 mg filmom obalené tablety_tbl flm_10/2024_REG.pdf
|
| PIL: |
PIL_Vortioxetín STADA 15 mg filmom obalené tablety_tbl flm_10/2024_REG.pdf
|
| Safety feature | Yes |
| Data update: | 22.11.2024 |
